By Kate Hammeke, Director of Marketing Intelligence, Nice Insight
The 2014 results from Nice Insight’s annual pharmaceutical and biotechnology outsourcing survey show positive news for both sides of outsourcing relationships. Just as there was an increase from 2012 to 2013 (up 7 percent, from 31 percent to 38 percent) in respondents with an outsourcing expenditure between $10 million and $50 million, there was another 9 percent increase in this expenditure bracket for the year ahead. Slightly under half of all survey respondents (47 percent) stated they will spend between $10 million and $50 million on outsourced projects in 2014.
By Oliver Stauffer, PTI Packaging and Inspection Systems
Blister package manufacturing for tablets and capsules has process and material parameters that are unique to each product. Barrier properties of blister packaging are primarily designed to eliminate moisture ingress, a result of H2O molecules passing through micro-leaks over extended periods of time.
By Dr. Dorian Dixon, Nanotechnology and Advanced Materials Institute, University of Ulster
A new white paper on the integrity of pharmaceutical packaging, by a leading packaging expert from the University of Ulster, Dr. Dorian Dixon, has established that existing methods for testing the seal integrity of blister packs are not as accurate as newer, technology-based test equipment.
By Morgan Polen, VP of Application Technology, Lighthouse Worldwide Solutions
Environmental monitoring is an important aspect of regulatory and quality control in the production of pharmaceuticals. The manufacturing environment must be controlled and monitored during the production of drugs. Final drug products must be sterile and free from contamination.
By Arthur Papineau, BS ChE, MBA; and John Klostermyer, Ph.D., STERIS Life Sciences
Whether it is a new laboratory research facility or renovation of an existing facility, a sound commissioning process is vital to start-up success.
By Bruce McDuffee, Marketing Manager, Vaisala Life Science Division
According to the FDA document titled Investigations Operations Manual (IOM), the form FDA 483 INSPECTIONAL OBSERVATIONS is intended for use in notifying the inspected establishment's top management, in writing, of "... significant objectionable conditions, relating to products and/or processes, or other violations of the FD&C Act and related Acts which were observed during the inspection." This statement, and other background information, can be found in section 5.2.3: Reports of Observations of the IOM.
By Jeff Clark, 7P Solutions™, LLC
The transportation and logistics world is accustomed to complying with regulations — from the Department of Transportation (DOT), to the International Air Transport Association (IATA), as well as country-specific import and export regulations. With the implementation of Good Distribution Practices (GDP) in the European Union, it is inevitable that the U.S. will follow suit, and the Food and Drug Administration (FDA) will adopt GDP as well. This is the foundation for securing the "identity, strength, quality, and purity" of all pharmaceutical products as defined in 21 CFR Part 211, Current Good Manufacturing Practices for Finished Pharmaceuticals (cGMP).
By Tom Burton, President Liquidity Services' Capital Asset Group
Whether a small enterprise or large institution, many organizations have and will be faced with the challenge of closing a lab. No matter what the size or scope of the closure, the person tasked with closing the facility faces a daunting assignment: millions of dollars in real estate, laboratory equipment, and research devices will need to be redeployed, sold, or disposed of.
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